A Survey of Microbiology for the Pharmaceutical, Biotechnology, and Medical Device Industries
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Who Should Attend
This course is intended for anyone in the medical manufacturing environment where product sterility or control of microbial contamination is essential. This includes Pharmaceutical, Biotech and Medical Device personnel in areas such as:
• Quality Assurance
• Maintenance
• Production
• Training
• Validation
• Purchasing
• Technical Support
Description
This 90-minute accredited online training will address the fundamental microbiological concepts that need to be understood by staff associated with the medical products manufacturing field. The concepts will be presented in terms that will be understood by non-microbiologists.
Discussions will include: personnel behavior practices, cleaning, sanitization, disinfection, and sterilization methods. In addition, the impact of raw materials (such as ingredients and packaging materials), equipment design, environment, manufacturing time frames, compressed gasses and water will be addressed.
Module 1: What is aseptic fill, and where are aseptic fill practices required?
Microbiology Basics such as:
• Growth requirements
• Sources of contamination
• Disinfection
• Sterilization
Module 2: Environmental controls:
• Personnel issues
• Production procedures
• Room layout in aseptic fill operations
Module 3: Monitoring of:
• Materials
• People
• Areas
• Equipment
• Production processes during aseptic fill
Validation
Publications
Resources
Question and Answer Session